Pharmacy Compliance in the ASC

1. Pharmacy Compliance in the ASC Christopher M. Dembny R.Ph. Nov 7, 2013

2. Compounding Pharmacies Necessary? Evil? Necessary Evil?

3. Biography • Christopher M. Dembny R.Ph. • Licensed pharmacist in Texas for 30 years • Consultant pharmacist for surgery centers for 20 years • Exclusively practicing in surgery centers and surgical hospitals for 13 years. • Currently consulting for > 70 ASC’s • ****Feel free to ask questions!

4. Who has regulatory oversight? • 1. FDA • 2. DEA • 3. Texas DPS* • 4. State Board of Pharmacy * • 5. Texas DSHS • 6. JCAHO (if you pay them) • 7. AAAHC (if you pay them) • 8. CMS $$$ **

5. What does the TSBP want to see? • 1. Annual controlled substance inventory • notarized • 2. CII invoices with DEA 222…or CSOS In separate file (signed by RPh and person receiving) • 3. Power of attorney to sign DEA 222 • 4 CIII-V invoices (separate) (signed) • 5. Controlled substance reproducible audit trail ****

7. What does the TSBP want to see? • Controlled substance administration records • Date and time of administration • Patient name • Drug and dose administered • Signature of person administering *** • Waste (if any) and signature of person witnessing waste • Ordering practitioner • Must be maintained separately from chart

8. What does the TSBP want to see? • 6. Library is adequate: • A. Pharmacy Rules • B. General Reference Text (Facts & Comp) • C. Drug Interaction text • D. Injectable Products • E. Antidotes and poison control # • F. Weight conversion chart

9. What does the TSBP want to see? • 7. Controlled substance documentation • 8. Removal of stock log • 9. Policies and Procedures(see list in TPR 291.76) • 10. Licenses – Pharmacy, DPS, and DEA

10. What does the TSBP want to see? • 11. “Adequate security” • 12. Transfers to other registrants • 13. Loss or theft reports – DEA 106 • Theft or significant loss • 14. Save for 2 years • 15. Pyxis – Omnicell??????

11. What does the DPS want to see? Licenses Adequate security Reproducible audit trail Secure prescription pads Annual inventories

12. What does DSHS/CMS look for?

13. CMS – CFR 416.48 • § 416.48 Condition for coverage—Pharmaceutical • services. • The ASC must provide drugs and • biologicals in a safe and effective manner, • in accordance with accepted professional • practice, and under the direction • of an individual designated responsible • for pharmaceutical services. (TPR 291.76) • (a) Standard: Administration of drugs. • Drugs must be prepared and administered • according to established policies • and acceptable standards of practice.

14. CMS – CFR 416.48 • (1) Adverse reactions must be reported • to the physician responsible for • the patient and must be documented in • the record. • (2) Blood and blood products must be • administered by only physicians or registered • nurses. • (3) Orders given orally for drugs and • biologicals must be followed by a written • order, signed by the prescribing • physician. • (b) [Reserved]

15. DEA • They’ll tell you what they’re looking for. • I’ve never seen them visit when there wasn’t already a problem.

16. Questions?????

17. Compounding Pharmacies Necessary? Evil? Necessary Evil?

18. How did we get here? • Drug shortages are worse than ever. • Cause (my opinion) • A. Online ordering • 1. everyone orders the cheapest product B. Lowers price and profit for manufacturer

19. How did we get here? • C. Forces some manufacturers out of business • D. Others make EXACTLY what they think they will sell. With smaller profit margins, profit disappears if you make too much. • E. Now we have fewer manufacturers with less overstock.

20. How did we get here? • F. Interruption of supply • 1. Natural disaster • 2. FDA shutdown • 3. Internal problem (strike – retooling) • If 1 of 10 manufacturers experiences an interruption, no problem • If 1 of 2 manufacturers experiences an interruption, BIG PROBLEM. SHORTAGES.

21. Problem created • A. Shortages of necessary drugs 1. Fentanyl 2. Midazolam 3. Propofol • Shortages of Crash Cart Drugs 1. Mag Sulfate 2. Sodium Bicarbonate

22. Are Compounding Pharmacies a viable answer? • Yes, but choose carefully. • Get approval from Med Exec. • The cheapest isn’t always the best. • The cheapest isn’t always the cheapest -- Ask those who used NECC.

23. Picking a good compounder • A. Look for accreditation: • Pharmacy Compounding Accreditation Board (PCAB) • An independent accreditation organization • Appear to be the only one • Very stringent • Can’t ensure everything is perfect

24. Picking a good compounder • B. Independent assessment • Consultant pharmacist can be a resource • International Association of Compounding Pharmacists (IACP) http://www.iacprx.org/ • http://www.iacprx.org/associations/13421/files/CPAQ%20REV%20with%20updated%20member%20number%20October%202012.pdf • This is the assessment tool from IACP

25. Picking a good compounder • C. Consultant Pharmacist Assessment • D. I would use in-state compounders • FDA may prohibit shipping across state lines.

26. Picking a good compounder • ************************************ • D. Ask for independent analysis • 1. Sterility a. bacterial b. fungal • 2. Quantitative Analysis

28. Contact Information • Christopher M. Dembny R.Ph. • cdembny@tx.rr.com